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Completed

NCT Number: NCT05329155

Early Administration of Heparin At FMC for PPCI of STEMI Patients

Heparin is the first choice of anticoagulation drug for primary PCI of STEMI patients. However, the priority of use of hepairn in first medical contact or in Cathlab has not yet studied. Previous study revealed early use of antithrombotic drugs could improve patient's survival. Here we supposed that use of heparin at first medical contact could increase the TIMI flow 3 grade ratio in STEMI patients and improve patient's survival and/or reduce MACE rather than in Cathlab.

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Key information

Conditions

STEMI Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Primary PCI ST Elevation Myocardial Infarction Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Renmin Hospital of Wuhan university

Wuhan, Hubei, 430000, China

About this study

This study will recruit 944 STEMI patients undergoing primary PCI with the symptom onset within 12 hours in 36 hospitals in Hubei Province, China. The patients will be 1:1 randomly assigned to the intervention group (IG) and control group (CG). Patients in IG will be intravenously administrated with sodium heparin (100U/Kg) at first medical contact, while patients in CG will be administrated with sodium heparin (100U/Kg) through catheter sheath in the CathLab.

Inclusion criteria

STEMI patient; Symptom onset in 12 hours; Intended to perform PPCI. Exclusion Criteria:Active bleeding; Life expectancy less than 1 year; History of heparin-induced thrombocytopenia; Mechanical complication of MI (VSR, acute MR); History of CABG; On Coagulation drugs; CPR before randomization; Pregnant or lactating woman;Refused to sign the Informed Consent Form.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • STEMI patient; Symptom onset in 12 hours; Intended to perform PPCI

Exclusion criteria

  • Active bleeding; Life expectancy less than 1 year; History of heparin-induced thrombocytopenia; Mechanical complication of MI (VSR, acute MR); History of CABG; On Coagulation drugs; CPR before randomization; Pregnant or lactating woman.

Treatment and study plan

Heparin sodium injection

Drug

Heparin Sodium Injection (100U/Kg body weight)

Primary outcomes

  1. The TIMI 3 flow of the infarct related artery before PPCI

    Time frame: Coronary angiography, before PPCI，anticipated within 2 hours after randomization

    The TIMI 3 flow of the infarct related artery at diagnostic angiography before PPCI

Secondary outcomes

  1. Major adverse cardiovascular or cerebrovascular event

    Time frame: 30 day and 1 year after randomization

    death, cardiac death, admission for heart failure, myocardial infarction, stent thrombosis, unplanned revascularization, and stroke

  2. Major bleeding

    Time frame: 30 day after randomization

    BARC ≥2

  3. Complete epicardial and myocardial reperfusion after PPCI

    Time frame: within 90min after PPCI

    Thrombolysis in myocardial infarction (TIMI) flow grade (TFG) 3 for epicardial reperfusion and TIMI myocardial perfusion (TMPG) grade 3 for myocardial reperfusion and complete (≥70%) ST-segment resolution of the initial sum of ST-segment elevation (STR) 90 minutes after PPCI.

Sponsors and collaborators

Lead sponsor

Renmin Hospital of Wuhan University

Other

Collaborators

  • Anlu People's Hospital
  • CR & WISCO General Hospital
  • Caidian People's Hospital
  • Chibi General Hospital
  • Ezhou Central Hospital
  • Fifth Hospital in Wuhan
  • General Hospital of Yangtze River shipping
  • Guoyao Dongfeng General Hospital
  • Hanyang University
  • Hubei University of Medicine
  • Hubei Zhongshan Hospital
  • Jiangling People's Hospital
  • Jiangxia First People's Hospital
  • Jingzhou Central Hospital
  • Laohekou First Hospital
  • People's Hospital of Jingshan
  • People's Hospital of Tongcheng
  • Shiyan People's Hospital
  • Songzi People's Hospital
  • The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture
  • The Central Hospital of Huanggang
  • Tianmen First People's Hospital
  • Wuhan Central Hospital
  • Wuhan Hospital of Traditional Chinese Medicine
  • Wuhan No.1 Hospital
  • Wuhan No.6 Hospital
  • Wuhan Puren Hospital
  • Wuhan Third Hospital
  • Wuxue First People's Hospital
  • Xiangyang Central Hospital
  • Xianning Central Hospital
  • Xianning First People's Hospital
  • Xiantao First People's Hospital
  • Xishui People's Hospital
  • Yichang Central People's Hospital

Registry information

Official study title

Effectiveness and Safety of Early Administration of Heparin At First Medical Contact for STEMI Patients Undergoing Primary Percutaneous Coronary Intervention: a Multicenter, Prospective, Randomized, Controlled Study

Acronym: HELP-PCI

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Apr 14, 2022
Registry last updated
Mar 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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